SNORE SAT RECORDER, MODEL SS41— 510(k) K002159

Name: FDA 510(k) clearance K002159
Creator: U.S. Food and Drug Administration
Published: 2002-06-28

Substantially Equivalent

Sagatech Electronics, Inc.

FDA 510(k) clearance K002159 for SNORE SAT RECORDER, MODEL SS41, Substantially Equivalent on 2002-06-28. Applicant: Sagatech Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Sagatech Electronics, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2000-07-17
Decision date: 2002-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, Alberta, CA

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Recent devices under product code MNR

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Recalls naming K002159

K-number listed on FDA's recall record

Z-1725-2013 — Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.Class II·Terminated·SagaTech Electronics, Inc.·20080508

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002159.

Data sourced from openFDA. This site is unofficial and independent of the FDA.